What this Trial Is About

Researchers are evaluating the safety and effectiveness of OH2, an oncolytic virus developed from herpes simplex virus type 2, alone or combined with HX008, an anti-PD-1 antibody, in patients with malignant solid tumors such as gastrointestinal cancers, head and neck cancers, and soft tissue sarcomas. OH2 is designed to selectively replicate in tumors and deliver a gene that may boost the immune response against cancer. This phase I/II study aims to identify safe dosage levels and observe anti-tumor activity in these patients. In phase I, patients receive intratumoral injections of OH2 at escalating doses either alone or combined with HX008 to determine dose-limiting toxicities and maximum tolerated doses. After establishing recommended doses, phase II includes four groups: one receiving OH2 alone, one receiving OH2 with irinotecan for gastrointestinal cancers, and two groups receiving OH2 combined with HX008 with different timing of the first HX008 dose. Viral spread is monitored through blood, urine, saliva, and injection site swabs during phase I. Participants undergo evaluations including imaging scans, lesion measurements, and response assessments using RECIST and iRECIST criteria. Safety is monitored by recording adverse events and toxicities using standard criteria. Researchers assess viral distribution and biological effects over six months and track anti-tumor activity for up to two years. The study involves regular visits for treatment and thorough monitoring to understand OH2’s potential in treating solid tumors.

OH2 Oncolytic Viral Therapy in Solid Tumors